OPEN-LABEL STUDY OF THE EFFICACY, SAFETY, AND TOLERABILITY OF POLICOSANOL IN PATIENTS WITH HIGH GLOBAL CORONARY RISK

In the present open-label, short-term study the effects of policosanol in the treatment of patients with type II hypercholesterolemia and hi gh global coronary risk were investigated. After dietary stabilization during a 5-week baseline period, 54 patients were instructed to take policosanol 20 mg once daily with the evening meal for 8 weeks. Ail of the patients had a family history of death caused by coronary artery disease and one or more personal coronary risk factors other than hype rcholesterolemia leg, hypertension [64.8%], previous coronary events [ 40.7%], smoking [31.5%], and obesity [18.5%]). Fifty percent of the pa tients were postmenopausal women and 24.1% were men aged >45 years. In addition, 25 patients (46.3%) showed severe hypercholesterolemia (tot al cholesterol >7.8 mmol/L). At 8 weeks, policosanol significantly red uced low-density Lipoprotein cholesterol (LDL-C) (22.6%) and total cho lesterol (16.9%) and significantly increased high-density lipoprotein cholesterol (HDL-C) (20.0%). Consequently, the ratios of total cholest erol:HDL-C and LDL-C:HDL-C decreased significantly (25.5% and 29.9%, r espectively). Triglycerides did not change significantly after treatme nt with policosanol. Forty patients (80%) of the 50 patients who compl eted the study had >15% reductions in LDL-C levels after 8 weeks of th erapy. The treatment was well tolerated. No drug-related clinical or b lood biochemical adverse effects were detected. Four patients reported mild adverse effects, but none of the patients withdrew from the stud y because of such effects. The present study suggests that policosanol 20 mg once daily in patients with type II hypercholesterolemia and hi gh global coronary risk was safe, well tolerated, and effective in low ering cholesterol. This highest recommended dosage needs to be studied further among a larger population for a longer duration to make recom mendations for lowering cholesterol and to judge the effects of polico sanol on the outcomes of patients with global coronary risk.